A female contraceptive device that can only be removed along with one or more organs was a bad idea from the beginning, according to lawyers representing women forced to undergo hysterectomies.
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The Essure device was marketed to Australian women for nearly two decades until 2017 when it was discontinued by manufacturer Bayer for commercial reasons.
But lawyers claiming negligence and breach of consumer laws in Australia say there's much more to it than that.
A class action is being led by Victorian woman Patrice Turner, who at 32 underwent a hysterectomy five years after having the device inserted.
Essure worked by inserting tightly wound 4cm coils through the vagina and uterus into the fallopian tubes, which are "substantially smaller" than the device when expanded.
It's designed to cause cellular injury to the fallopian tubes, inflammation and then scar tissue, which results in the intended contraceptive effect.
Ms Turner, a mother-of-three, had no history of any troubling gynaecological conditions before the device.
She is one of the women the class action argues was left with chronic inflammation that caused debilitating symptoms, including bleeding and pain that at times was severe and almost constant.
She bled through clothes and bedsheets, her ability to care for and enjoy time with her children was severely impaired and her relationship with her partner suffered.
Immediately after the hysterectomy, including removal of the devices, her symptoms went away.
"We say the Essure device was the cause of her symptoms," Fiona Forsyth KC told the Victorian Supreme Court on Tuesday.
While Slater and Gordon represent 1000 women in the class action, Ms Turner's case is the only one that will be examined in the 12-week trial.
In a joint defence, the six companies including Bayer Australia and German parent company Bayer AG, say there's no "signature" Essure injury that the women can point to as the cause of their symptoms.
They also argue the two principal symptoms said to result from use of the device - chronic pelvic pain and abnormal uterine bleeding, are commonly experienced by women of reproductive age.
"Inevitably, a significant number of those women would have suffered from one or both of those conditions in any event," their written defence says.
Ms Forsyth said that submission revealed the attitude of Bayer toward group members, arguing the companies couldn't escape liability by writing off problematic effects as "common women's symptoms".
"A gynaecological device can't just escape scrutiny because the problems it potentially causes or exacerbates include chronic pain or abnormal uterine bleeding," she said.
"That would mean it would be very difficult to ever find a gynaecological device defective - and it's particularly problematic when the result is many young women ending up with a hysterectomy."
She told Justice Andrew Keogh there was a steady escalation of reports of adverse effects in 2014 and an exponential increase in later years.
It first came to the attention of regulators in 2015 when the US Food and Drug Administration ordered a study into chronic pain and abnormal uterine bleeding.
Ms Forsyth said the defendants described expert evidence about mechanisms by which the devices allegedly caused injury as being "novel scientific hypotheses".
But she said those hypotheses were the specific focus of the FDA-ordered study, which is still underway.
"We say what's novel is putting a permanent device into a woman's anatomy which can't be removed without surgery, which is designed to elicit a chronic inflammatory response," Ms Forsyth said.
In August 2020, Bayer agreed to pay $US1.6 billion ($A2.5 billion) to settle cases with up to 39,000 American women, without admissions of wrongdoing or liability.
In a statement Bayer told AAP it stands behind the safety and efficacy of Essure, which was supported by 10 clinical trials and 70 real-world observational studies internally and by independent researchers.
It has cited commercial reasons for discontinuation of the device in Australia in 2017, and worldwide since December 2018, previously noting "reduced patient interest in permanent birth control".
Australian Associated Press
